FDA Label for Itch Relief
View Indications, Usage & Precautions
Itch Relief Product Label
The following document was submitted to the FDA by the labeler of this product Humn Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Allantoin 0.6% (w/w)
Lidocaine Hydrochloride 4.0% (w/w)
Menthol 1.0% (w/w)
Otc - Purpose
Purpose
Skin protectant
Anesthetic
Analgesic, anesthetic, and antipruritic
Indications & Usage
Uses
Temporary relief of:
• pain • itching
Associated with:
▪ insect bites ▪ minor skin irritations
Temporary protection of minor skin irritations
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
in large quantities, particularly:
• over raw surfaces • over blistered areas
Otc - Ask Doctor
Ask a doctor before use
if child is under 2 years of age, and use only as directed
Otc - When Using
When using this product
• avoid contact with eyes; if this happens, rinse thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if
• condition worsens • if symptoms persist for more than 7 days
• clear up and occur again within a few days • you experience: pain, swelling, or blistering
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Information For Patients
Other information
• do not use if seal is broken
• store at 60-85° F
Inactive Ingredient
Inactive ingredients
Acrylates/Acrylamide Copolymer, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.
Otc - Questions
Questions?
1-866-335-3596 Monday to Friday 8 am to 6 pm EST .
Package Label.Principal Display Panel
Itch Relief Label.jpg
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